Joel Laudenbach, DMD 1

Transcription

1 Oral Lesion Biopsy & Adjunc5ve Screening Device Techniques Workshop Joel M. Laudenbach, DMD Diplomate, American Board of Oral Medicine Coordinator, Advanced Oral Diagnosis Workgroup Assistant Prof., Oral Medicine & Geriatric Private Oral Medicine prac9ces: Los Angeles & Mission Viejo, California Western University of Health Sciences, College of Dental Medicine Medical Staff, Cedars-Sinai Medical Center Disclosures: No financial investment with Henry Schein, OralCDx BrushTest, Zila, ViziLite Plus, Tblue, Microlux, VELscope, CTP/Dentrix, OralID, CytID, Goccles *Identafi Oral Lesion Screening Device dona5on by DentalEZ to be used in prac5ce & at WesternU *VELscope Oral Lesion Screening Device with ipod Touch a]achment dona5on by LED Dental to be used at WesternU *DentalEZ and VELscope are suppor5ng the biopsy & adjunc5ve device workshop (Saturday, April 28) Past clinical inves5gator: ViziLite/TBlue, Oral cytology for RNA analysis Consul5ng: Disclosures: Medscape.com/WebMD Author ADA Council on Scien5fic Affairs Oral Medicine Clinical Assistance Programs oral mucosi5s educator for OC/OP cancer drug studies Private Oral Medicine Prac5ce Toluidine blue dye Joel Laudenbach, DMD 1

2 Lesion assessment protocol Clinical history, past medical history Identafi Examina5on: Visualiza5on Palpa5on Descrip5on & documenta5on Lesion assessment protocol Differen5al diagnosis Proceed with tes5ng, management and / or referral Goals: Establish the diagnosis & rule out pre-cancer / cancer Oral lesion biopsy techniques Oral cancer & pre-cancer (dysplasia) Adjunc5ve techniques Apply new concepts / techniques Biopsy Screening for oral cancer: a targeted evidence update Outside the USA, screening lowered the stage of cancer at diagnosis & improved 5-year survival Screening tobacco & alcohol subgroups reduced mortality rate US Preven5ve Services Task Force Recommenda5ons 4/2013 Oral cavity cancer sta5s5cs 2017 est. ~ 4,700 Canadians diagnosed with OCC ~ 3,200 men and ~ 1,450 women ~ 1250 Canadians will die from OCC Oropharyngeal cancer sta5s5cs Canadians diagnosed with OPC 131 Canadians died from OPC Sta5s5cs & risk factors Oral cavity & oropharyngeal cancer vs. Oral cavity & pharynx cancer Source: Canadian Cancer Society Estimates for2017. Source: Canadian Cancer Society Estimates for2017. American Cancer Society. Cancer Facts & Figures 2017 & Joel Laudenbach, DMD 2

3 Oral cavity & oropharyngeal cancer [ACS 2018] 51,540 es5mated new cases in US 2018 ~ 10,030 people will die of these cancers *Avg. age of diagnosis: 62 yrs. > 1/4 ( ~ 12,900 ) occur in pa5ents < 55 yrs. male:female ra5o 2:1 Oral & pharyngeal cancer [ACS 2018] Tongue cancer - 5-year rela5ve survival rates: Based on stage of cancer: Localized = 78 % Regional = 63 % Distant = 36 % (NCI SEER Data ) Oral & pharyngeal cancer [ACS 2018] Floor of mouth cancer - 5-year rela5ve survival rates: Based on stage of cancer: Localized = 75 % Regional = 38 % Distant = 20 % (NCI SEER Data ) Oral & pharyngeal cancer [ACS 2018] Oropharynx & tonsil - 5-year rela5ve survival rates = 66% Gums & other parts of mouth - 5-year rela5ve survival rates = 60% (NCI SEER Data ) Oral cavity & oropharyngeal cancer North America = USA + Canada Men Most common sites: tongue (25-30%), tonsils (15-20%), and oropharynx - Gingiva, floor of mouth, lips and minor salivary glands (palate) Lip, other mouth & other pharyngeal Oral tongue cancer - Squamous cell carcinoma - most common malignancy (oral cavity) Oropharyngeal cancer Joel Laudenbach, DMD 3

4 North America = USA + Canada Women Tongue, Salivary gland & Oropharyngeal cancer Canada* Oral tongue cancer US* No adjuncts replace the diagnos5c Gold Standard. Scalpel 5ssue biopsy & histologic assessment JADA May 2010 No clinically evident lesion or symptom No clinically evident lesion or symptom Globus sensa5on feels like something is lodged in throat Clinically evident, innocuous or non-suspicious lesion Unexplained ear pain otalgia Unexplained oropharyngeal pain Hoarseness / change in voice Joel Laudenbach, DMD 4

5 Clinically evident, suspicious lesion Seemingly malignant lesion Clinicians* should General den5sts Obtain or Update Comprehensive Hx: Along with lesion evalua5on Specialists Hygienists Consider signs & symptoms of disease: Globus sensa5on Unexplained ear pain - otalgia Oropharyngeal pain hoarseness Clinicians* should Poten5ally Malignant Disorders - PMDs General den5sts Specialists Hygienists Perform an intraoral & extraoral conven9onal visual & tac9le exam in all adult pa9ents JADA 2017 Leukoplakia Erythroplakia Erythroleukoplakia Submucous fibrosis Hereditary disorders with increased risk of malignant transforma5on Fanconi anemia Heavy tobacco use Heavy alcohol use Lichen planus* Immediate referral to specialists that have advanced training in:! If suspicious Lesion Oral and Maxillofacial Surgery Oral and Maxillofacial Pathology Oral Medicine Periodontology Otolaryngology-Head and Neck Surgery (ENT) JADA 2017 JADA 2017 Joel Laudenbach, DMD 5

6 2017 JADA Panel does not recommend: Cytologic, autofluorescence, 5ssue reflectance, or vital staining adjuncts for the evalua5on of PMDs in adult pt s with:! If suspicious Lesion! If suspicious lesion Clinically evident, seemingly innocuous lesions Suspicious lesions JADA 2017 JADA 2017 OralCDx BrushTest Finding dysplasia is the key to preven5ng cancer All of these 9ssue changes or spots are confirmed dyplasias Joel Laudenbach, DMD 6

7 The BrushTest The BrushTest Non-Homogenous surfaced leukoplakia The BrushTest technique The BrushTest technique Hold the slide up to a light ensure the cellular material is visible on the slide Apply Fixa*ve by flooding slide with liquid Joel Laudenbach, DMD 7

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9 Brush - interpreta9on of results: insufficient basal cell count (2-7%) nega9ve : no cellular abnormali5es posi9ve : defini5ve cellular evidence of epithelial dysplasia or carcinoma atypical : abnormal cellular changes warran5ng further inves5ga5on Evidence-based recommenda5ons - screening for oral SCCa Insufficient evidence to support recommenda5on for or against use of [transepithelial cytology]* in seemingly innocuous lesions Rethman MP et al. JADA May 2010 Evidence-based recommenda5ons - screening for oral SCCa In suspicious lesions, [transepithelial cytology]* has validity iden5fying disaggregated dysplas5c cells** Poten5al use: mul5ple lesions (& no history of oral cancer), noncompliant pa5ents, complex medical status, severe access-to-care restraints Rethman MP et al. JADA May 2010! If suspicious lesion How helpful is cytologic tes5ng in triaging the need for biopsy? Clinically evident, innocuous or non-suspicious lesion Innocuous (non-suspicious) oral cavity lesions: True-Posi5ve Rate = 0.96 True-Nega5ve Rate = 0.90 JADA 2017 Lingen et al. JADA 2017:148(11): How helpful is cytologic tes5ng in triaging the need for biopsy? Suspicious (PM/M) oral cavity lesions: True-Posi5ve Rate = 0.92 True-Nega5ve Rate = 0.94 Lingen et al. JADA 2017:148(11): Cytologic adjunct tests Provider & pa5ent should consider the longterm downstream consequences of: True posi5ve, false posi5ve, true nega5ve, false nega5ve results Discuss with pa5ent in detail in the context of informed consent* Include point that surgical biopsy/histology is the defini5ve procedure that establishes/rules out dysplasia and neoplasia Cytologic adjunct tests Most importantly clinicians need to periodically monitor cytology test nega5ve pa5ents Minimize downstream consequences of poten5al false nega5ve result To avoid a delayed defini5ve diagnosis or treatment Joel Laudenbach, DMD 9

10 New Clinical Pathway It s OK to use cytologic test in the limited scenario when a pa5ent declines biopsy or immediate referral to a specialist Does not men5on toluidine blue dye, 5ssue reflectance, autofluorescence or salivary adjuncts to help triage a lesion Ctyology Tests Available Oral CDx TheBrushTest OralCyte Liquid-based cytology Gynemed Brush ClearPrep OC OralCyte - Liquid-based cytology Benefits: Limita9ons: Blood, inflamma5on & mucus are reduced Exfolia9ve cytology* Cells are distributed randomly; on clear background Reduce # of unsa5sfactory slides Joel Laudenbach, DMD 10

11 Cytology - informed consent Fully inform pa5ents about test limita9ons Surgical biopsy with pathologist diagnosis is the only defini5ve way to rule out pre-cancer and cancer Cytologic tes5ng is NOT a biopsy Cytologic tes5ng is NOT a replacement for biopsy Cytologic test consent Is associated with false + and false - results Associated with delays in diagnosis of precancer and cancer Obtain firm, pa5ent commitment to long-term follow-up care Cytologic test consent Well-documented re-evalua5on program & schedule Pa5ent aware they can always proceed with having scalpel biopsy and/or referral to specialist any5me* Tissue reflectance / chemiluminescence enhance iden5fica5on of oral mucosal abnormali5es Use a~er conven5onal oral examina5on* Tissue reflectance / chemiluminescence ViziLite - How it works 1% ace5c acid rinse Removes debris, dehydrates epithelial cells Blue-white illumina5on glow s5ck Normal 5ssue blue Abnormal 5ssue dis5nctly white / acetowhite Joel Laudenbach, DMD 11

12 ViziLite Plus lesion iden5fica5on *Reported improvements in: Visualiza5on* Brightness* Margin delinea5on / sharpness Surface texture Evidence-based recommenda5ons - screening for oral SCCa Insufficient evidence to show that 9ssue reflectance improves detec5on beyond the conven5onal exam Use of these devices can be associated with increased false-posi9ve findings 2017 JADA Panel does not recommend: Cytologic, autofluorescence, 5ssue reflectance, or vital staining adjuncts for the evalua5on of PMDs in adult pt s with: Clinically evident, seemingly innocuous lesions Suspicious lesions 1% toluidine blue 1% ace5c acid Rethman MP et al. JADA May % toluidine blue / tolonium chloride Dye (dark royal blue vs. pale blue) May stain nucleic acids, abnormal 5ssue Demarcate extent of lesion before excision High sensi5vity for detec5ng carcinomas Use for detec5ng recurrences Posi5ve in ~50% of dysplas5c lesions tol. blue used on leukoplakia Diagnosis: chronic hyperplas5c candidiasis Ram S, Siar CH. Int J Oral Maxillofac. Surg. 2005;34: Joel Laudenbach, DMD 12

13 Increased Risk for Oral Leukoplakia Progression to Malignancy: +Dysplasia on 1 st biopsy Larger size > 200 mm 2 Homogenous surfaced leukoplakia Subsite tongue or floor of mouth Non-homogenous appearance* Older age Female Absence of known risk factors ELP Non-Homogenous surfaced leukoplakia Prevalence of Dysplasia (pre-cancer) in Oral Leukoplakias = 16 39% Dye is unable to penetrate through thick hyperkerato5c leukoplakias False nega5ve result** GOCF 2016 Prevalence of Dysplasia/Cancer of True Leukoplakias = 43% Woo et al. 14 toluidine blue dye Stains: Ac5ve inflammatory, ulcera5ve, regenera5ng lesions Mechanically retained: Dorsum of tongue filiform papillae Dental plaque Crevices of rough & fissured lesions High false posi5ve rate Schedule repeat stain in 2 weeks* Evidence-based recommenda5ons - screening for oral SCCa Insufficient evidence for or against stand-alone use of toluidine blue to enhance iden5fica5on of poten5ally malignant lesions in the general popula5on Rethman MP et al. JADA May 2010 *Evidence-based recommenda5ons - screening for oral SCCa ** Toluidine blue may assist in assessment of poten5ally malignant lesions if: History of oral cancer >50 yrs. who smoke and drink alcohol When used by dental or medical providers with advanced training/experience** *Rethman MP et al. JADA May 2010 **Speight PM et al. OOOO & GOCF 2016 Joel Laudenbach, DMD 13

14 2017 JADA Panel does not recommend: Cytologic, autofluorescence, 5ssue reflectance, or vital staining adjuncts for the evalua5on of PMDs in adult pt s with: Direct 5ssue fluorescence / autofluorescence Clinically evident, seemingly innocuous lesions Suspicious lesions Also seen with prominent surface vascularity (inflammation) & melanin pigmentation invasive carcinoma vs. normal 5ssue Fluorescence at 365 nm 405 nm 450 nm diascopic fluorescence Is applica5on of pressure onto lesion **Dysplas5c changes can be found in lesions that: Do autofluoresce (look green) Do have loss of autofluorescence (look dark) and blanch Clin Cancer Res Poh et al. DYSPLASIA CANCER VELscope 20 tumors Margin iden5fica5on beyond tumor Evidence-based recommenda5ons - screening for OSCCa Insufficient evidence to show that 5ssue autofluorescence improves detec5on beyond the conven5onal exam Use of these devices can be associated with increased false-posi5ve findings Rethman MP et al. JADA May 2010 Joel Laudenbach, DMD 14

15 Evidence-based recommenda5ons - screening for OSCCa Some evidence: 5ssue autofluorescence* may improve determina5on of surgical margins & selec5on of op5mal biopsy site in large or mul5focal lesions or during surgery 2017 JADA Panel does not recommend: Cytologic, autofluorescence, 5ssue reflectance, or vital staining adjuncts for the evalua5on of PMDs in adult pt s with: Clinically evident, seemingly innocuous lesions Suspicious lesions Identafi Clinical Examples What you will normally see Rethman MP et al. JADA May 2010 The Exam (Part 1) Put the glasses on and begin the exam with White Light The Exam (Part 2) Whether suspicious 5ssue or not, switch to violet for a second observa5on The Exam (Part 3) If you see dark spots or suspicious 5ssue with violet, switch to Green-Amber and look for an increase in redness or blood vessels surrounding the area Biopsy Informed Consent Start with standard oral surgical consent Review benefits, alterna5ves, risks and financial implica5ons Biopsy Informed Consent Add/clarify based on your planned procedure Post-opera5ve pain, numbness, 5ngling, paresthesia: All of these can be short-term and/or long-term/ permanent Nadeau C, Kerr AR. Dent Clin N Am 62 (2018) Add/clarify based on your planned procedure: A]ached gingiva biopsy risk for addi5onal gingival recession* Persistent recession may require Periodontal surgery to repair Mucocele removal / labial mucosa procedures: possible post-opera5ve swelling weeks at site of biopsy that requires another surgical removal procedure Joel Laudenbach, DMD 15

16 Biopsy Informed Consent Armamentarium Tongue biopsy: Inform pa5ent about possible post-opera5ve neck pain, dysphagia/odynophagia and/or myalgia/ TMD. Pulling tongue, surgery on the tongue and holding jaw open are risk factors for above post-opera5ve symptoms Dr. Crispian Scully Local anesthesia 30 gauge short needle #15 scalpel blade #12 scalpel blade 5 mm punch scalpel Minnesota retractor 2 mouth mirror retractors Hemostat with gauze pad Co]on plier pickup Hemosta5c agents: ViscoStat, silver nitrate 5p Needle driver, scissors 4-0 chromic gut suture 2 x 2 gauze pads Lab supplies 10% formalin, forms, mailing supplies Oral pathology lab Lab choice: insurances accepted/processed Private (cash) vs. In-network for medical insurance Strengths of each lab Communicate lab fees* $ / sample Proper forms completed: Lab consents, Medicare, copy of pa5ent s current medical insurance. Joel Laudenbach, DMD 16

17 Addi5onal considera5ons: Bx Sampling error possible Delay in diagnosis Tissue fluorescence autofluorescence i.e., VELscope, Identafi, OralID, others Diagnosis: moderate epithelial dysplasia / pre-cancer False nega5ve reports are possible Even scalpel Bx has up to 23% false nega5ve rate* Persistent lesions should have 5ssue biopsy Joel Laudenbach, DMD 17